Hyrimoz

As monotherapy or in combination w/ MTX or other DMARDs for reducing signs & symptoms, inhibiting structural damage progression & improving physical function in adult patients w/ moderately to severely active RA who have had inadequate response to ≥1 DMARDs. In combination w/ MTX for patients w/ recently diagnosed moderate to severely active RA who have not received MTX. As monotherapy or in combination w/ DMARDs for reducing signs & symptoms of active arthritis in adult patients w/ moderate to severe psoriatic arthritis when response to previous DMARD therapy has been inadequate. Reduces signs & symptoms in adult patients w/ active ankylosing spondylitis who have had inadequate response to conventional therapy. Moderate to severe active Crohn's disease in adults to reduce signs & symptoms of disease, to induce & maintain clinical remission in patients who have had inadequate response to conventional therapies or who have lost response to or are intolerant of infliximab. In combination w/ corticosteroids for induction treatment; may be given as monotherapy in case of intolerance or when continued treatment is inadequate w/ corticosteroids. Moderately to severely active ulcerative colitis in adult & ped patients ≥5 yr who have had inadequate response to conventional therapy including corticosteroids &/or 6-mercaptopurine or azathioprine, or who are intolerant to or have medical CI for such therapies. Adult patients w/ moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy & when other systemic therapies are medically less appropriate. Active moderate to severe hidradenitis suppurativa (HS) in adults & adolescents ≥12 yr w/ inadequate response to conventional systemic HS therapy. Non-infectious intermediate, posterior & panuveitis in adult patients who have had inadequate response to corticosteroids, in need of corticosteroid-sparing or in whom corticosteroid is inappropriate. In combination w/ MTX for active polyarticular juvenile idiopathic arthritis (pJIA) in patients ≥2 yr who have had inadequate response to ≥1 DMARDs; may be given as monotherapy in case of intolerance or when continued treatment is inappropriate w/ MTX. Active enthesitis-related arthritis in patients ≥6 yr who have had inadequate response to or are intolerant of conventional therapy. Reduces signs & symptoms, induces & maintains clinical remission in ped ≥6 yr w/ moderately to severely active Crohn's disease who have had inadequate response to conventional therapy. Severe chronic plaque psoriasis in childn & adolescents ≥4 yr who have had inadequate response to or inappropriate candidates for topical therapy & phototherapy. Chronic non-infectious anterior uveitis in ped ≥2 yr who have had inadequate response to or are intolerant to conventional therapy or in whom conventional therapy is inappropriate.

SC RA, psoriatic arthritis & ankylosing spondylitis Adult 40 mg every other wk as single dose. Crohn's disease Adult Induction: Initial dose (day 0): 80 mg. 2nd dose (day 14): 40 mg. Maintenance: 40 mg starting day 28 & continuing fortnightly. If more rapid response is needed, may be given as 160 mg at wk 0 (160 mg in 1 day or 80 mg/day for 2 consecutive days) then 80 mg at wk 2. Ped 6-17 yr weighing ≥40 kg Induction: 80 mg at wk 0 & 40 mg at wk 2. If more rapid response is needed, may be given as 160 mg at wk 0 & 80 mg at wk 2. Maintenance dose starting at wk 4: 40 mg every other wk, may increase to 40 mg every wk or 80 mg every other wk if insufficient response, <40 kg Induction: 40 mg at wk 0 & 20 mg at wk 2. If more rapid response is needed, may be given as 80 mg at wk 0 & 40 mg at wk 2. Maintenance dose starting at wk 4: 20 mg every other wk, may increase to 20 mg every wk if insufficient response. Ulcerative colitis Adult 160 mg at wk 0 (160 mg in 1 day or 80 mg/day for 2 consecutive days) & 80 mg at wk 2. After induction treatment, 40 mg every other wk. Ped 5-17 yr weighing ≥40 kg Induction: 160 mg at wk 0 & 80 mg at wk 2. Maintenance dose starting at wk 4: 80 mg every other wk or 40 mg every wk, <40 kg Induction: 80 mg at wk 0 & 40 mg at wk 2. Maintenance dose starting at wk 4: 40 mg every other wk or 20 mg every wk. Plaque psoriasis Adult Initially 80 mg followed by 40 mg every other wk starting 1 wk after initial dose. Ped 4-17 yr weighing ≥30 kg Initially 40 mg followed by 40 mg every other wk starting 1 wk after initial dose, 15 to <30 kg Initially 20 mg followed by 20 mg every other wk starting 1 wk after initial dose. HS Adult Initially 160 mg at day 1 (160 mg in 1 day or 80 mg/day for 2 consecutive days) followed by 80 mg at day 15. On day 29, continue at 40 mg every wk or 80 mg every other wk. Adolescent ≥12 yr weighing at least 30 kg 80 mg at wk 0 followed by 40 mg every other wk starting at wk 1. If inadequate response, give as 40 mg every other wk, may consider increase to 40 mg every wk or 80 mg every other wk. Uveitis Adult Initially 80 mg followed by 40 mg every other wk starting 1 wk after initial dose. Ped ≥2 yr weighing ≥30 kg Loading dose: 80 mg 1 wk prior to start of maintenance therapy. Maintenance: 40 mg every other wk in combination w/ MTX, <30 kg Loading dose: 40 mg 1 wk prior to start of maintenance therapy. Maintenance: 20 mg every other wk in combination w/ MTX. pJIA Ped ≥2 yr weighing ≥30 kg 40 mg every other wk, 10 to <30 kg 20 mg every other wk. Enthesitis-related arthritis Ped ≥6 yr weighing ≥30 kg 40 mg every other wk, 15 to <30 kg 20 mg every other wk.

Hypersensitivity. Active TB or other severe infections (eg, sepsis, abscesses & opportunistic infections). Moderate to severe heart failure (NYHA class III/IV).

Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants

L04AB04 - adalimumab ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.

POM